Understanding FDA Approval for Sweeteners
In the United States, any new food ingredient, including high-intensity sweeteners, must be proven safe for consumption before being added to food. The FDA regulates these substances in two primary ways: by approving them as food additives or by accepting that they are Generally Recognized as Safe (GRAS).
The FDA Food Additive Approval Process
For a substance to be approved as a food additive, manufacturers must submit data demonstrating its safety for premarket review by the FDA. This process is comprehensive and includes extensive toxicological studies and human clinical trials. Once approved, the additive can be used within specific conditions outlined by the FDA, with an Acceptable Daily Intake (ADI) established for consumption.
The Generally Recognized as Safe (GRAS) Designation
A substance can bypass the formal food additive approval process if its safety is widely recognized by a panel of qualified experts based on publicly available scientific information. This is known as GRAS status. A company can determine a substance is GRAS independently or notify the FDA of its conclusion. The FDA has reviewed and not objected to the GRAS status of several high-intensity sweeteners derived from natural sources.
The Six FDA-Approved Artificial Sweeteners (Food Additives)
The FDA has approved the following six synthetic sweeteners as food additives, meaning they have undergone rigorous safety reviews:
- Saccharin: First discovered in 1879, it is 200–700 times sweeter than sugar and is used in a wide variety of foods. Saccharin is heat stable and sold under brand names like Sweet'N Low. While once thought to be a carcinogen based on animal studies in the 1970s, subsequent research found no evidence of a link to cancer in humans, and the warning label was removed in 2000.
- Aspartame: Composed of two amino acids (aspartic acid and phenylalanine), aspartame is 180–200 times sweeter than sugar. It is not heat stable and loses its sweetness when heated, making it unsuitable for baking. Brand names include Equal and NutraSweet. A warning label for people with the rare genetic disorder phenylketonuria (PKU) is required on aspartame-containing products.
- Acesulfame Potassium (Ace-K): Approximately 200 times sweeter than sugar, Ace-K is heat stable and often blended with other sweeteners to mask a slight aftertaste. Brand names include Sunett and Sweet One. It is used in baked goods, soft drinks, and many other products.
- Sucralose: This no-calorie sweetener is about 600 times sweeter than sugar. Made from sugar, sucralose is heat stable and widely used for baking and in many foods and beverages. The most common brand name is Splenda.
- Neotame: A derivative of aspartame, neotame is 7,000–13,000 times sweeter than sugar. It is heat stable and can be used as both a general-purpose sweetener and a flavor enhancer. It is processed differently than aspartame, so it does not pose a risk for individuals with PKU. The brand name is Newtame.
- Advantame: The newest sweetener to be approved as a food additive by the FDA in 2014, advantame is about 20,000 times sweeter than sugar. Like neotame, it is heat stable and safe for individuals with PKU.
Generally Recognized as Safe (GRAS) High-Intensity Sweeteners
These sweeteners have a GRAS designation, meaning expert consensus supports their safe use.
- Steviol Glycosides (from Stevia): Highly purified extracts from the leaves of the stevia plant are 200–400 times sweeter than sugar and are considered GRAS. Brand names include Truvia and PureVia. The FDA has not authorized the use of whole-leaf or crude stevia extracts as sweeteners.
- Monk Fruit Extract: Also known as luo han guo, extracts from this fruit are 100–250 times sweeter than sugar and are considered GRAS. Examples include Monk Fruit in the Raw and PureLo.
- Thaumatin: A protein isolated from the West African katemfe fruit, thaumatin is a GRAS-recognized sweetener that is 2,000–3,000 times sweeter than sugar.
Sweetener Comparison Table
| Sweetener | Regulatory Status | Sweetness (vs. Sugar) | Heat Stability | Common Brand Names |
|---|---|---|---|---|
| Saccharin | Food Additive | 200–700x | Yes | Sweet'N Low |
| Aspartame | Food Additive | 180–200x | No | Equal, NutraSweet |
| Acesulfame K | Food Additive | ~200x | Yes | Sweet One, Sunett |
| Sucralose | Food Additive | ~600x | Yes | Splenda |
| Neotame | Food Additive | 7,000–13,000x | Yes | Newtame |
| Advantame | Food Additive | ~20,000x | Yes | (None widely marketed) |
| Steviol Glycosides | GRAS | 200–400x | Yes | Truvia, PureVia |
| Monk Fruit Extract | GRAS | 100–250x | Yes | Monk Fruit in the Raw |
| Thaumatin | GRAS | 2,000–3,000x | Yes | Talin |
Considerations When Using Artificial Sweeteners
When selecting a sugar substitute, it's wise to consider your specific needs and potential sensitivities. Key factors include:
- Intended Use: Some sweeteners, like aspartame, lose their sweetness when exposed to high heat, making them a poor choice for baking, while others, like sucralose and Ace-K, are heat stable.
- Taste Profile: Certain sweeteners, such as Ace-K, may have a noticeable aftertaste, which is why they are often combined with other sweeteners. Natural sweeteners like stevia can also have a distinct taste.
- Individual Health Concerns: People with phenylketonuria (PKU) must avoid aspartame, and some individuals may experience gastrointestinal distress with certain sugar alcohols.
- Moderation is Key: While FDA-approved, the overall use of sweeteners is best done in moderation as part of a balanced diet. Relying on nutrient-dense whole foods is generally preferable to substituting them with sweetened products.
Conclusion
For those seeking alternatives to sugar, the FDA has provided a safe and well-regulated list of options. The six high-intensity sweeteners approved as food additives—saccharin, aspartame, acesulfame potassium, sucralose, neotame, and advantame—have undergone extensive testing to confirm their safety under approved use conditions. Additionally, several naturally derived sweeteners like purified steviol glycosides and monk fruit extract hold GRAS status. Consumers should consider the unique properties and potential side effects of each sweetener, paying attention to specific health warnings like the one for aspartame regarding PKU. Used responsibly within the established ADI, these approved sweeteners offer a viable way to reduce sugar intake without compromising on sweetness.
Learn more about sweeteners on the official FDA website: High-Intensity Sweeteners
